IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system
The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in...
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Veröffentlicht in: | Journal of pharmaceutical sciences 2009-06, Vol.98 (6), p.2001-2009 |
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container_title | Journal of pharmaceutical sciences |
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creator | Buch, Philipp Langguth, Peter Kataoka, Makoto Yamashita, Shinji |
description | The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in order to simulate the effect of food on the absorption of fenofibrate. Moreover, the results obtained from the D/P system were correlated with pharmacokinetic parameters obtained following in vivo studies in rats. The in vitro parameter (amount permeated in the D/P system) reflected well the in vivo performance in rats in terms of AUC and Cmax of fenofibric acid. This study thus demonstrates the potential of the D/P system as valuable tool for absorption screening of dosage forms for poorly soluble drugs. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2001–2009, 2009 |
doi_str_mv | 10.1002/jps.21576 |
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Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in order to simulate the effect of food on the absorption of fenofibrate. Moreover, the results obtained from the D/P system were correlated with pharmacokinetic parameters obtained following in vivo studies in rats. The in vitro parameter (amount permeated in the D/P system) reflected well the in vivo performance in rats in terms of AUC and Cmax of fenofibric acid. This study thus demonstrates the potential of the D/P system as valuable tool for absorption screening of dosage forms for poorly soluble drugs. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2001–2009, 2009</description><identifier>ISSN: 0022-3549</identifier><identifier>EISSN: 1520-6017</identifier><identifier>DOI: 10.1002/jps.21576</identifier><identifier>PMID: 18855916</identifier><identifier>CODEN: JPMSAE</identifier><language>eng</language><publisher>Hoboken: Elsevier Inc</publisher><subject>Absorption ; Administration, Oral ; Animals ; Biological and medical sciences ; biopharmaceutics classification system (BCS) ; Caco-2 Cells ; Chemistry, Pharmaceutical - instrumentation ; Chemistry, Pharmaceutical - methods ; dissolution ; Fenofibrate - blood ; Fenofibrate - chemistry ; Fenofibrate - metabolism ; Fenofibrate - pharmacokinetics ; food-effect-studies ; General pharmacology ; Humans ; Hypolipidemic Agents - blood ; Hypolipidemic Agents - chemistry ; Hypolipidemic Agents - metabolism ; Hypolipidemic Agents - pharmacokinetics ; in vitro/in vivo correlations (IVIVC) ; Male ; Medical sciences ; Permeability ; permeation ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Rats ; Rats, Wistar ; Solubility ; Tablets - chemistry ; Tablets - metabolism ; Tablets - pharmacokinetics</subject><ispartof>Journal of pharmaceutical sciences, 2009-06, Vol.98 (6), p.2001-2009</ispartof><rights>2008 Wiley-Liss, Inc.</rights><rights>Copyright © 2008 Wiley‐Liss, Inc.</rights><rights>2009 INIST-CNRS</rights><rights>(c) 2008 Wiley-Liss, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5016-2b7c5735a48932f59d9211aca9d9b0703983327d28d417d49d1fe286e55d22d23</citedby><cites>FETCH-LOGICAL-c5016-2b7c5735a48932f59d9211aca9d9b0703983327d28d417d49d1fe286e55d22d23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjps.21576$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjps.21576$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,27929,27930,45579,45580</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21657183$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18855916$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Buch, Philipp</creatorcontrib><creatorcontrib>Langguth, Peter</creatorcontrib><creatorcontrib>Kataoka, Makoto</creatorcontrib><creatorcontrib>Yamashita, Shinji</creatorcontrib><title>IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system</title><title>Journal of pharmaceutical sciences</title><addtitle>J. Pharm. Sci</addtitle><description>The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in order to simulate the effect of food on the absorption of fenofibrate. Moreover, the results obtained from the D/P system were correlated with pharmacokinetic parameters obtained following in vivo studies in rats. The in vitro parameter (amount permeated in the D/P system) reflected well the in vivo performance in rats in terms of AUC and Cmax of fenofibric acid. This study thus demonstrates the potential of the D/P system as valuable tool for absorption screening of dosage forms for poorly soluble drugs. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2001–2009, 2009</description><subject>Absorption</subject><subject>Administration, Oral</subject><subject>Animals</subject><subject>Biological and medical sciences</subject><subject>biopharmaceutics classification system (BCS)</subject><subject>Caco-2 Cells</subject><subject>Chemistry, Pharmaceutical - instrumentation</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>dissolution</subject><subject>Fenofibrate - blood</subject><subject>Fenofibrate - chemistry</subject><subject>Fenofibrate - metabolism</subject><subject>Fenofibrate - pharmacokinetics</subject><subject>food-effect-studies</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>Hypolipidemic Agents - blood</subject><subject>Hypolipidemic Agents - chemistry</subject><subject>Hypolipidemic Agents - metabolism</subject><subject>Hypolipidemic Agents - pharmacokinetics</subject><subject>in vitro/in vivo correlations (IVIVC)</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Permeability</subject><subject>permeation</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Rats</subject><subject>Rats, Wistar</subject><subject>Solubility</subject><subject>Tablets - chemistry</subject><subject>Tablets - metabolism</subject><subject>Tablets - pharmacokinetics</subject><issn>0022-3549</issn><issn>1520-6017</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU1v1DAQhi0EosvCgT-AfAGph3T9EcfJES10u6jiQ0CRuFiOMwGXJA6eBNh_j7e7lAucPJKfecfzmJDHnJ1xxsTqesQzwZUu7pAFV4JlBeP6LlmkO5FJlVcn5AHiNWOsYErdJye8LJWqeLEgX7dX26s19QMN0XbU1hjiOPkw0DZE2sIQWl9HOwH1fQ-N31cROrAIdLJ1BxPSGf3whVraeMTQzfvu1QixB3sThDucoH9I7rW2Q3h0PJfk4_nLD-uL7PLNZrt-fpk5xXiRiVo7paWyeVlJ0aqqqQTn1tlU1EwzWZVSCt2Issm5bvKq4S2IsgClGiEaIZfk2SF3jOH7DDiZ3qODrrMDhBlNoXlRScUTeHoAXQyIEVozRt_buDOcmb1Wk7SaG62JfXIMnetk4S959JiAp0fAorNdG-3gPN5yghdK8_TyJVkduJ--g93_J5pXb9__GZ0dOnyy-Ou2w8ZvaRWplfn0emPyFzLf6IvP5l3i5YGHJPmHh2jQeRhc-rsIbjJN8P9Y8DdPQa-e</recordid><startdate>200906</startdate><enddate>200906</enddate><creator>Buch, Philipp</creator><creator>Langguth, Peter</creator><creator>Kataoka, Makoto</creator><creator>Yamashita, Shinji</creator><general>Elsevier Inc</general><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley</general><general>American Pharmaceutical Association</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200906</creationdate><title>IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system</title><author>Buch, Philipp ; Langguth, Peter ; Kataoka, Makoto ; Yamashita, Shinji</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5016-2b7c5735a48932f59d9211aca9d9b0703983327d28d417d49d1fe286e55d22d23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Absorption</topic><topic>Administration, Oral</topic><topic>Animals</topic><topic>Biological and medical sciences</topic><topic>biopharmaceutics classification system (BCS)</topic><topic>Caco-2 Cells</topic><topic>Chemistry, Pharmaceutical - instrumentation</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>dissolution</topic><topic>Fenofibrate - blood</topic><topic>Fenofibrate - chemistry</topic><topic>Fenofibrate - metabolism</topic><topic>Fenofibrate - pharmacokinetics</topic><topic>food-effect-studies</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>Hypolipidemic Agents - blood</topic><topic>Hypolipidemic Agents - chemistry</topic><topic>Hypolipidemic Agents - metabolism</topic><topic>Hypolipidemic Agents - pharmacokinetics</topic><topic>in vitro/in vivo correlations (IVIVC)</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Permeability</topic><topic>permeation</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. 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Pharm. Sci</addtitle><date>2009-06</date><risdate>2009</risdate><volume>98</volume><issue>6</issue><spage>2001</spage><epage>2009</epage><pages>2001-2009</pages><issn>0022-3549</issn><eissn>1520-6017</eissn><coden>JPMSAE</coden><abstract>The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in order to simulate the effect of food on the absorption of fenofibrate. Moreover, the results obtained from the D/P system were correlated with pharmacokinetic parameters obtained following in vivo studies in rats. The in vitro parameter (amount permeated in the D/P system) reflected well the in vivo performance in rats in terms of AUC and Cmax of fenofibric acid. This study thus demonstrates the potential of the D/P system as valuable tool for absorption screening of dosage forms for poorly soluble drugs. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2001–2009, 2009</abstract><cop>Hoboken</cop><pub>Elsevier Inc</pub><pmid>18855916</pmid><doi>10.1002/jps.21576</doi><tpages>9</tpages></addata></record> |
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subjects | Absorption Administration, Oral Animals Biological and medical sciences biopharmaceutics classification system (BCS) Caco-2 Cells Chemistry, Pharmaceutical - instrumentation Chemistry, Pharmaceutical - methods dissolution Fenofibrate - blood Fenofibrate - chemistry Fenofibrate - metabolism Fenofibrate - pharmacokinetics food-effect-studies General pharmacology Humans Hypolipidemic Agents - blood Hypolipidemic Agents - chemistry Hypolipidemic Agents - metabolism Hypolipidemic Agents - pharmacokinetics in vitro/in vivo correlations (IVIVC) Male Medical sciences Permeability permeation Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Rats Rats, Wistar Solubility Tablets - chemistry Tablets - metabolism Tablets - pharmacokinetics |
title | IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system |
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